Developing Chinese Approach to Rare Disease Data Trust——From the Perspective of Formulating the"Stipulation of Shanghai Municipality on Promoting the Development of Drugs for Rare Diseases in Pudong New Area"
Rare disease data sharing is key to solving difficulties in diagnosis and treatment and improving drug accessibility,thus it is imperative to overcome challenges of data silos and the high costs of research and development through collaboration among entities and unified legislation.In the context of the promulgating"Opinions on Establishing Basic System on Data to Better Play the Role of Data as A Productive Factor",the exploitation and utilization of the value of data as a productive factor are constantly promoted to form rare disease data sharing mode consistent with medical data sharing,however,the existing model design cannot meet the needs of development in the rare disease field and still faces many practical challenges.As an innovative model,data trust,due to its advantages in balancing data rights,ensuring data security,and promoting efficient data utilization,shows a high degree of compatibility with the rare disease sector.Based on this,rare disease data sharing should be grounded in practical needs,by leveraging the advantages of Pudong New Area regulations in pioneering trial and taking patients'needs as the starting point,to establish basic principles of sharing,openness,and public welfare.At the same time,attention is paid to the protection of personal privacy and data security to develop Chinese approach to rare disease data trust by optimizing rules on income distribution.Finally,it is advisable to realize the spillover of the effect of data trust and promote all entities to jointly address the challenges of rare diseases.
Rare DiseaseMedical DataData Sharing ModelData TrustPersonal Privacy and Data Security
万方数据
